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Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

University at Buffalo (UB) logo

University at Buffalo (UB)

Status and phase

Withdrawn
Phase 3

Conditions

Sleep Apnea

Treatments

Other: computer model
Other: Polysomnogram

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics.

The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must be an adult (≥18 years old)
  • Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.

Exclusion criteria

  • Pregnancy or breast feeding
  • Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction < 35%).
  • Patients with end-stage renal disease on hemodialysis
  • Patients with CVA, Parkinson, neuromuscular degenerative disease.
  • Patient on narcotics.
  • Patients with severe lung disease requiring oxygen at night and/or during the day.
  • Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

artificial neural network
Experimental group
Treatment:
Other: computer model
Polysomnogram
Active Comparator group
Treatment:
Other: Polysomnogram

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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